Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population (OPUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01411202
First received: June 13, 2011
Last updated: August 4, 2011
Last verified: August 2011

June 13, 2011
August 4, 2011
June 2011
February 2012   (final data collection date for primary outcome measure)
Time to pleurodesis [ Time Frame: up to 90 days post PleurX insertion ] [ Designated as safety issue: No ]
measured in days after Pleurx catheter insertion up to 90 days
Same as current
Complete list of historical versions of study NCT01411202 on ClinicalTrials.gov Archive Site
  • Pleurodesis rates at 90 days post Pleurx insertion [ Time Frame: 90 days post Pleurx insertion ] [ Designated as safety issue: No ]
    defined by the BTS guidelines, where complete pleurodesis is defined as lack of fluid re-accumulation, allowing for removal of the pleural catheter. Failed pleurodesis is defined as re-accumulation of fluid and symptoms requiring repeated pleural procedures
  • Number of participants with adverse events [ Time Frame: 90 days post Pleurx insertion ] [ Designated as safety issue: Yes ]
    Most common complications include: pleural infection / cellulitis, pain, catheter obstruction and symptomatic loculated effusion. Other adverse events will also be collected.
  • Effects on pulmonary function [ Time Frame: 90 days post Pleurx insertion ] [ Designated as safety issue: No ]
    Pulmonary Function testing will be performed prior to and post PleurX catheter insertion and prior to each follow up visit
Same as current
Not Provided
Not Provided
 
Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population
Outpatient Pleurodesis Using Sclerosants(OPUS):Comparing Doxycycline Pleurodesis to Continued Drainage With the Pleurx Catheter System in the Treatment of Malignant Pleural Effusions in the Outpatient Setting

Patients with cancer may experience problems with their breathing due to a fluid accumulation around their lungs called malignant pleural effusion (MPE). This fluid can be drained but draining may not stop the fluid from accumulating again. MPE can cause shortness of breath during activity and at rest leaving patients feeling as though they cannot catch their breath enough to be comfortable. Other symptoms can include pain, cough and weight loss.

One way to stop the fluid from accumulating is to create scar tissue between the lung and chest wall so there is no more room for fluid accumulation. This procedure is called pleurodesis. Pleurodesis is the standard of care at most centres across Canada. This procedure is done by injecting a drug into the space between the lung and chest wall through a catheter, Doxycycline is one of the drugs currently used for this purpose. Traditionally, patients are admitted for pleurodesis, mostly because the size of the catheter used to inject the medication is very large but also because of the potential complications that can happen with these larger chest tubes.

At our centre, most patients with MPE are managed at home with a smaller sized catheter known as a Pleurx catheter. The Pleurx catheter allows patients to remain at home for treatment and trained staff come into the home to both drain the MPE and monitor the patient. Sometimes, patients experience pleurodesis through use of the Pleurx catheter alone.

Pleurodesis with doxycycline can happen faster than with the Pleurx catheter alone. It has been our experience with a limited number of patients that it is safe to perform pleurodesis using the Pleurx catheter for doxycycline injection in an outpatient setting.

Malignant pleural effusions (MPE) occur in 25 - 50% of malignancies, represent advanced disease and carry with it significant morbidity. It is estimated that 75% of malignant effusions are symptomatic at the time of presentation, with dyspnea being the most common complaint. Cough, weight loss and chest pain may also be presenting symptoms. The diagnosis of MPE often carries with it a poor prognosis with an average survival of 3-9 months. Thus, management of MPE is generally palliative, aimed at alleviating the associated symptoms, while incurring minimal discomfort and disruption of patients activities of daily living. Limiting the number of days spent hospitalized ia also a consideration. Currently, the most common treatment for MPE involves tube thoracostomy and pleurodesis using a sclerosing agent. Use of Doxycycline as a sclerosing agent has been shown to be both safe and efficacious with only minor complications. Traditionally, pleurodesis with Doxycycline has been performed in the inpatient setting.

The Pleurx catheter (Cardinal Biomedical) is the only small bore catheter commercially available that has been specifically designed for long term indwelling drainage of MPE. In order to reduce the chance of dislodgement and minimize infection rates, it is tunnelled under the skin for approximately 5 cm before entering the pleural space. These indwelling catheters can provide excellent symptom control and have also been associated with spontaneous pleurodesis rates comparable to many chemical pleurodesis rates.

Pleurx has been compared to inpatient doxycycline pleurodesis via chest tube with no difference in survival, safety or efficacy noted. However, hospital stay was significantly shorter in the Pleurx group, 1 day versus 6.5 days.

The aim of this study is to determine the effectiveness of outpatient pleurodesis, using doxycycline administered via Pleurx catheter. This will be a randomized clinical trial comparing the time to pleurodesis in patients with malignant pleural effusion receiving doxycycline + Pleurx catheter versus Pleurx catheter alone.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Malignant Pleural Effusion
  • Drug: Doxycycline
    One time injection 500mg of powdered doxycycline reconstituted with 50cc of normal saline via Pleurx catheter
    Other Name: Doxycycline
  • Other: normal saline
    One time injection of normal saline (placebo) into Pleurx catheter
  • Experimental: Doxycycline
    Pleurx insertion with injection of 500mg of doxycycline in 50cc of normal saline.
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Normal Saline
    Pleurx insertion with placebo injection of 50cc of normal saline
    Intervention: Other: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Presence of symptomatic and moderate sized (>1/3 of hemithorax) MPE
  2. Persistent malignant pleural effusion that is free-flowing
  3. Symptomatic improvement after therapeutic thoracentesis
  4. Life expectancy of at least three months (duration of study follow-up)
  5. 90% radiographic apposition of parietal and visceral pleura
  6. Residence within 30 minute radius from The Ottawa Hospital

Exclusion Criteria:

  1. Previous lobectomy or pneumonectomy on affected side
  2. Multiple loculations
  3. Trapped or entrapped lung
  4. Untreated pleural infection
  5. Abnormal coagulation profile (INR>1.5 and / or platelet count <50 x 10*9/L)
  6. Planned intrapleural chemotherapy (however participants may receive concomitant systemic chemotherapy, mediastinal radiation therapy or steroids)
  7. Life expectancy less than 3 months
  8. Multiple co-morbidities limiting out-patient management of pleural effusion
  9. Tetracycline / Doxycycline allergy
Both
18 Years and older
No
Contact: Chantal Bornais, RN, BScN 613-737-8899 ext 75128 cbornais@toh.on.ca
Canada
 
NCT01411202
2008362-01H
Yes
Dr. K. Amjadi, Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: K. Amjadi, MD, FRCPC Ottawa Hospital
Ottawa Hospital Research Institute
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP